Methods for managing scalp conditions

ABSTRACT

This application relates to a pharmaceutical composition for the prevention, treatment, and management of scalp conditions, such as dandruff, seborrheic dermatitis, psoriasis, folliculitis, and hair thinning including a therapeutically effective amount of an acidic component of a hydroxyacid or tannic acid, or a pharmaceutically acceptable salt thereof. A preferred anti-dandruff composition and method of managing dandruff includes a therapeutically effective amount of the acid component, a vitamin A component, and an anti-growth agent. A preferred anti-hair thinning composition and method of managing thinning hair includes a therapeutically effective amount of the acidic component, a niacin component present in an amount sufficient to locally increase blood circulation, and a 5-α reductase inhibitor. The invention also relates to a method of treating chemically processed hair by administering to a patient an amount of an acidic component of a hydroxy acid or tannic acid, or a pharmaceutically acceptable salt thereof, in an amount sufficient to essentially close the cuticle and inhibit modification of the chemically processed hair.

TECHNICAL FIELD

[0001] This application relates to pharmaceutical compositions, as wellas methods, to normalize skin for the prevention, treatment, andmanagement of scalp conditions.

BACKGROUND OF THE INVENTION

[0002] Human skin is a composite material of the epidermis and thedermis. The topmost part of the epidermis is the stratum corneum. Thislayer is the stiffest layer of the skin, as well as the one mostaffected by the surrounding environment. Below the stratum corneum isthe internal portion of the epidermis. Below the epidermis, the topmostlayer of the dermis is the papillary dermis, which is made of relativelyloose connective tissues that define the micro-relief of the skin. Thereticular dermis, disposed beneath the papillary dermis, is tight,connective tissue that is spatially organized. The reticular dermis isalso associated with coarse wrinkles. At the bottom of the dermis liesthe subcutaneous layer.

[0003] The principal functions of the skin include protection,excretion, secretion, absorption, thermoregulation, pigmentogenesis,accumulation, sensory perception, and regulation of immunologicalprocesses. These functions are detrimentally affected by, for example,dryness, yeast, and structural changes in the skin, such as due to agingand excessive sun exposure.

[0004] Many hair care products tend to include alkaline components,which tend to open pores in the scalp. While these products may improveor alter hair appearance, they may exacerbate various scalp conditions,such as dandruff, psoriasis, and seborrhea.

[0005] Various pharmaceuticals that frequently contain one or more alphahydroxy acids, such as glycolic acid, have been used to prevent andtreat certain cellular, skin, hair and other conditions. For example,U.S. Pat. No. 4,668,509 discloses polythioalkanecarboxylic anionicproducts and their preparation and use in cosmetic compositions and hairtreatment compositions, such as shampoos.

[0006] U.S. Pat. No. 4,814,166 discloses polyanionic oligomer compoundssuitable for use in keratin fiber treatment, such as hair, which may beadministered in a shampoo. These compounds are alleged to hold hair withsuppleness and without significant hardening of the hair.

[0007] U.S. Pat. No. 5,344,971 discloses mercapto acids, such asthiolactic acid (2-mercaptopropionic acid), that are used as reducingagents for the permanent reshaping of hair or for depilatory milks andcreams.

[0008] An article entitled “Hydroxy Acids and Skin Aging” discloses theuse of hydroxy and other acids as skin peels and emollients that canmoisturize, stimulate, and exfoliate the skin. [Smith, W.,Soap/Cosmetics/Chemical Specialties, pp. 54-58, 76, September, 1993.]. Astudy was conducted with hydroxy, keto, carboxylic, or dicarboxylicacids, including glycolic and salicylic acids, to determine long-termrejuvenating benefits. The study noted that higher pH formulationsresulted in less stimulatory activity and lower irritation, andconcluded that various non-hydroxy acids would be expected to deliverlong-term rejuvenating benefits. Id. at 58.

[0009] One publication, WO 95/33438, discloses skin or hair careproducts having an agent acting cosmetically on the hair or skin, suchas thioglycolic acid preferably with an ammonium salt. The agent isabsorbed in a fibrous material containing amino groups, such ascellulose based-fiber containing polysilicic acid.

[0010] U.S. Pat. No. 5,422,370 discloses methods of using hydroxyacid orrelated compounds, such as alpha 2-hydroxypropanoic acid (lactic acid),for the treatment of wrinkles. These compounds are also disclosed to beeffective for enhancing the topical effects of other cosmetic andpharmaceutical agents for treatment of conditions such as dry skin,ichthyosis, eczema, palmar and plantar hyperkeratoses, dandruff, acne,pruritis, psoriasis, Darier's disease, lichen simplex chronicus, andwarts. Similarly, U.S. Pat. No. 5,547,988 discloses methods for reducingthe appearance of skin changes associated with aging, such as wrinkles,by topically applying a compound of glycolic acid, lactic acid, citricacid, or a salt thereof.

[0011] U.S. Pat. No. 5,587,149 discloses improved stable emulsions ofpolyethylene glycol-in-oil for topical application to the skin thatcontain one or more water soluble active ingredients, such as Vitamin C,glycolic acid, and the like.

[0012] Despite these references, there is still a need forpharmaceutical compositions and methods for the prevention, treatment,and management of scalp conditions, such as dandruff, psoriasis, andseborrhea. The present invention advantageously provides pharmaceuticalcompositions, as well as methods for prevention and treatment, byadministering such compositions to repair and normalize the scalp forthe prevention and treatment of scalp conditions.

SUMMARY OF THE INVENTION

[0013] The present invention relates to an anti-dandruff pharmaceuticalcomposition for administration to a scalp including an acidic componenthaving a hydroxy acid or tannic acid, or a pharmaceutically acceptablesalt thereof, in an amount sufficient to exfoliate at least a portion ofthe scalp, a vitamin A component in an amount sufficient to inhibitoverproduction of stratum corneum on the scalp, and an anti-growth agentto inhibit fungus, yeast, bacteria, or a mixture thereof adjacent thescalp. The compositions preferably include a pharmaceutically acceptablecarrier or excipient.

[0014] In one embodiment, the acidic component includes an alpha-hydroxyacid, beta-hydroxy acid or tannic acid, the vitamin A component includesretinyl palmitate, and the anti-growth agent includes clotrimazole. In apreferred embodiment, the acidic component includes at least one ofglycolic acid, lactic acid, citric acid, salicylic acid, or tannic acid.In another embodiment, the acidic component is present in an amount fromabout 0.1 to 8 weight percent, the vitamin A component is present in anamount from about 0.01 to 1 weight percent, and the anti-growth agent ispresent in an amount from about 0.1 to 1.5 weight percent, of thecomposition. In a preferred embodiment, the pharmaceutical compositionfurther includes at least one of a surfactant, a stabilizer, apreservative, a moisturizer, anti-inflammatory agent, anti-oxidant, anda coloring agent, which together may be present in an amount from about10.1 to 99.1 weight percent of the composition. Also encompassed by theinvention are a shampoo, cream, or gel including the pharmaceuticalcomposition described above.

[0015] The invention also relates to an anti-hair thinningpharmaceutical composition for administration to a scalp having anacidic component including a hydroxy acid or tannic acid in an amountsufficient to exfoliate at least a portion of the scalp, or apharmaceutically acceptable salt thereof, a niacin component present inan amount sufficient to locally increase blood circulation; and a 5-αreductase inhibitor in an amount sufficient to inhibit conversion oftestosterone to dihydro-testosterone. The compositions preferablyinclude a pharmaceutically acceptable carrier or excipient.

[0016] In one embodiment, the acidic component includes an alpha-hydroxyacid, beta-hydroxy acid, or tannic acid, the niacin component includesnicotinate, and the 5-α reductase inhibitor includes at least one offinasteride or Saw Palmetto Extract. In a preferred embodiment, theacidic component includes glycolic acid, lactic acid, citric acid,salicylic acid, or tannic acid. In another embodiment, the acidiccomponent is present in an amount from about 0.1 to 8 weight percent,the niacin component is present in an amount from about 0.01 to 1 weightpercent, and the 5-α reductase inhibitor is present in an amount fromabout 0.1 to 1 weight percent, of the composition. In a preferredembodiment, the composition includes at least one of a surfactant, astabilizer, a preservative, a moisturizer, anti-inflammatory agent,anti-oxidant, and a coloring agent, which together may be present in anamount from about 10.1 to 99.1 weight percent of the composition. In apreferred embodiment, the acidic component and the niacin component areadapted for topical administration and the 5-α reductase inhibitor isadapted for oral administration. The invention also encompasses ashampoo, cream, or gel including the pharmaceutical compositiondescribed above.

[0017] The invention also relates to a method of managing a scalpcondition which includes administering to a patient a therapeuticallyeffective amount of an acidic component having a hydroxy acid or tannicacid, or a pharmaceutically acceptable salt thereof, a vitamin Acomponent, and an anti-growth agent to inhibit fungus, yeast, bacteria,or a mixture thereof that may be present adjacent the scalp. In apreferred embodiment, the scalp condition treated is at least one ofdandruff, seborrheic dermatitis, psoriasis, folliculitis, or otherinfectious or scaling conditions.

[0018] In a preferred embodiment, the active ingredients areadministered topically. In another embodiment, the administering is byat least one of a shampoo, aerosol spray, gel, paste, cream, lotion,sponge, emulsion, or ointment. In a preferred embodiment, from about 1mg to 10,000 mg of the acidic component, vitamin A component, andanti-growth agent together are administered. In another embodiment, theacidic component, vitamin A component, and anti-growth agent areadministered concurrently. In another embodiment, the acidic component,vitamin A component, and anti-growth agent are administered concurrentlywith at least one additional pharmaceutical composition for theprevention or treatment of a scalp condition. In another embodiment, themethod further includes administering at least one of a surfactant,stabilizer, preservative, moisturizer, anti-inflammatory agent,anti-oxidant, or coloring agent. In a preferred embodiment, the acidiccomponent includes an alpha-hydroxy acid or tannic acid, the vitamin Acomponent includes retinyl palmitate, and the anti-growth agent includesclotrimazole.

[0019] The invention also relates to a method of managing hair thinningwhich includes administering to a patient a therapeutically effectiveamount of an acidic component having a hydroxy acid or tannic acid, or apharmaceutically acceptable salt thereof, a niacin component present inan amount sufficient to locally increase blood supply, and a 5-αreductase inhibitor.

[0020] In a preferred embodiment, the active ingredients areadministered topically. In a more preferred embodiment, the acidiccomponent and niacin component are topically administered and the 5-αreductase inhibitor is orally administered. In another embodiment, theadministering is by at least one of a shampoo, aerosol spray, gel,paste, cream, lotion, sponge, emulsion, or ointment. In a preferredembodiment, from about 1 mg to 10,000 mg of the acidic component, niacincomponent, and 5-α reductase inhibitor are administered. In anotherembodiment, the acidic component, niacin component, and 5-α reductaseinhibitor are administered concurrently. In yet another embodiment, theacidic component, niacin component, and 5-α reductase inhibitor areadministered concurrently with at least one additional pharmaceuticalcomposition for the prevention or treatment of a scalp condition. Inanother embodiment, the method further includes administering at leastone of a surfactant, stabilizer, preservative, moisturizer,anti-inflammatory agent, anti-oxidant, or coloring agent. In a preferredembodiment, the acidic component includes an alpha-hydroxy acid ortannic acid, the niacin component includes nicotinate, and the 5-αreductase inhibitor includes at least one of finasteride or Saw PalmettoExtract.

[0021] The invention further relates to a method of treating chemicallyprocessed hair having a plurality of cuticle by administering to apatient an amount of an acidic component including a hydroxy acid ortannic acid, or a pharmaceutically acceptable salt thereof, in an amountsufficient to essentially close the cuticle.

[0022] In a preferred embodiment, the administering is topicallyapplied. In another embodiment, the administering is by at least one ofa shampoo, aerosol spray, gel, paste, cream, lotion, sponge, emulsion,or ointment. In a preferred embodiment, from about 1 mg to 10,000 mg ofthe acidic component is administered. In another embodiment, the acidiccomponent is administered concurrently with at least one additionalpharmaceutical composition for the prevention or treatment of a scalpcondition. In a preferred embodiment, the method further includesadministering at least one of a surfactant, stabilizer, preservative,moisturizer, anti-inflammatory agent, anti-oxidant, or coloring agent.In another preferred embodiment, the acidic component includes analpha-hydroxy acid or tannic acid.

[0023] The ranges of the components of the pharmaceutical compositionmay vary, but the active ingredients should be understood to add to 100weight percent of the active pharmaceutical composition.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0024] A formulation for the prevention, treatment, and management ofscalp conditions, such as dandruff, psoriasis, and seborrhea, has nowbeen discovered. Moreover, the management of the scalp mayadvantageously be accomplished by the administration of thepharmaceutical composition of the present invention.

[0025] Methods for administering the compositions herein are alsoencompassed by the invention. Such methods include the prevention,treatment, or management of: dandruff, eczema, hair thinning,irritation, psoriasis, folliculitis, scaling, seborrhea or seborrheicdermatitis, all while reducing environmental damage to the hair andscalp and maintaining color in chemically processed hair as advantageousbenefits. The compositions may be prepared in high concentrations foradministration by professionals in a salon, as well as lowerconcentrations that are safer for home use. The methods of the presentinvention also include administering mono- or poly-hydroxy or tannicacids for treating chemically processed hair, which advantageouslycloses or essentially closes the hair cuticle. The closing of thecuticle helps “lock in” hair color to prevent fading or washout of thechemically processed hair.

[0026] The pharmaceutical composition includes the combination of anumber of different components that interact to provide the desiredimprovements to the skin. The compositions include an acidic componentincluding one or more mono- or poly-hydroxy acids or tannic acid, amixture thereof, or a pharmaceutically acceptable salt or ester thereof.One of ordinary skill in the art will be readily able to select andprepare suitable mono- or poly-hydroxy acids for use in the compositionof the invention, for example, alkyl hydroxycarboxylic acids, aralkyland aryl hydroxycarboxylic acids, polyhydroxy-carboxylic acids, andhydroxy-polycarboxylic acids. To assist one of ordinary skill in theart, some preferred mono- or poly-hydroxy acids include: 2-hydroxyaceticacid (glycolic acid); 2-hydroxypropanoic acid (lactic acid); 2-methyl2-hydroxypropanoic acid; 2-hydroxybutanoic acid; phenyl 2-hydroxyaceticacid; phenyl 2-methyl 2-hydroxyacetic acid; 3-phenyl 2-hydroxyaceticacid; 2,3-dihydroxypropanoic acid; 2,3,4-trihydroxybutanoic acid;2,3,4,5,6-pentahydroxyhexanoic acid; 2-hydroxydodecanoic acid;2,3,4,5-tetrahydroxypentanoic acid; 2,3,4,5,6,7-hexahydroxyheptanoicacid; diphenyl 2-hydroxyacetic acid; 4-hydroxymandelic acid;4-chloromandelic acid; 3-hydroxybutanoic acid; 4-hydroxybutanoic acid;2-hydroxyhexanoic acid; 5-hydroxydodecanoic acid; 12-hydroxydodecanoicacid; 10-hydroxydecanoic acid; 16-hydroxyhexadecanoic acid;2-hydroxy-3-methylbutanoic acid; 2-hydroxy-4-methylpentanoic acid;3-hydroxy-4-methoxymandelic acid; 4-hydroxy-3-methoxymandelic acid;2-hydroxy-2-methylbutanoic acid; 3-(2-hydroxphenyl) lactic acid;3-(4-hydroxyphenyl) lactic acid; hexahydromandelic acid;3-hydroxy-3-methylpentanoic acid; 4-hydroxydecanoic acid;5-hydroxydecanoic acid; aleuritic acid; 2-hydroxypropanedioic acid;2-hydroxybutanedioic acid; erythraric acid; threaric acid; arabiraricacid; ribaric acid; xylaric acid; lyxaric acid; glucaric acid;galactaric acid; mannaric acid; gularic acid; allaric acid; altraricacid; idaric acid; talaric acid; 2-hydroxy-2-methylbutanediodic acid;citric acid, isocitric acid, agaricic acid, quinic acid, glucoronicacid, glucoronolactone, galactoronic acid, galactoronolactone, uronicacids, uronolactones, ascorbic acid, dihydroascorbic acid,dihydroxytartaric acid, tropic acid, ribonolactone, gluconolactone,galactonolactone, gulonolactone, mannonolactone, citramalic acid;pyruvic acid, hydyroxypyruvic acid, hydroxypyruvic acid phosphate andesters thereof; methyl pyruvate, ethyl pyruvate, propyl pyruvate,isopropyl pyruvate; phenyl pyruvic acid and esters thereof; methylphenyl pyruvate, ethyl phenyl pyruvate, propyl phenyl pyruvate; formylformic acid and esters thereof; methyl formyl formate, ethyl formylformate, propyl formyl formate; benzoyl formic acid and esters thereof;methyl benzoyl formate, ethyl benzoyl formate and propyl benzoylformate; 4-hydroxybenzoyl formic acid and esters thereof;4-hydroxyphenyl pyruvic acid and esters thereof; and 2-hydroxyphenylpyruvic acid and esters thereof. The hydroxy acids are more preferablyselected from one or more alpha-hydroxy acids or beta-hydroxy acids,most preferably from glycolic, lactic, citric, or salicylic acid. Itshould be understood that one or more derivatives of the above acidiccomponent, such as esters or lactones thereof, are also suitably used.One of ordinary skill in the art will also understand that varioushydroxy acids described in U.S. Pat. Nos. 5,547,988 and 5,422,370 arealso suitable for use in the compositions and methods of the invention.The acidic component is present in the composition and methods in anamount sufficient to exfoliate, i.e., remove dead or dying skin cells,from at least a portion of the scalp. The acidic component is typicallypresent in an amount from about 0.1 to 8 weight percent, preferablyabout 0.5 to 5 weight percent, more preferably from about 1 to 3 weightpercent of the composition. For example, the acidic component may befrom about 0.2 to 10 weight percent GLYPURE, which contains 70 weightpercent glycolic acid, in combination with about 0.1 to 0.3 weightpercent salicylic acid.

[0027] Compositions and methods for managing dandruff, seborrheicdermatitis, psoriasis, folliculitis, and other scaling or infectious'scalp conditions, also include a vitamin A component and an anti-growthagent. The vitamin A component preferably is retinyl palmitate. Thevitamin A component is present in an amount sufficient to normalizeepidermal growth by inhibiting overproduction of the stratum corneum.The vitamin A component is typically present in an amount from about0.01 to 1 weight percent, preferably 0.05 to 0.8 weight percent, andmore preferably 0.1 to 0.5 weight percent of the composition. Vitamin Ais toxic at high levels, such that no more than 400,000 IU should becumulatively ingested per day for greater than six months.

[0028] Any pharmaceutically acceptable anti-growth agent may be used,preferably an antifungal agent, antiyeast agent, or antibacterial agent,more preferably triclosan, clotrimazole, and the like, and mixturesthereof. The anti-growth agent is typically present in an amount fromabout 0.1 to 1.5 weight percent, preferably from about 0.3 to 1.2 weightpercent, and more preferably from about 0.5 to 1 weight percent of thecomposition. The anti-growth agent may inhibit the fungus Pityrosporumovale, which tends to be present in patients having dandruff orseborrheic dermatitis. Together, the acidic component, Vitamin Acomponent, and anti-growth agent facilitate exfoliation of dead skin,facilitate hydration of the scalp, and inhibit the presence of yeast orfungus, such as all of which assist in the management of dandruff,psoriasis, folliculitis, seborrheic dermatitis, and other inflammatoryor scaling conditions of the scalp.

[0029] Compositions and methods for the management of thinning hairinclude a niacin component and a 5-α reductase inhibitor, in addition tothe acidic component. The niacin component (vitamin B₃) may be anypharmaceutically acceptable niacin component, preferably niacinamide ornicotinate, more preferably nicotinate. The niacin component should bepresent in an amount sufficient to facilitate improved blood circulationin the scalp, which may help inhibit hair loss. Thus, the niacincomponent is typically present in an amount from about 0.01 to 1 weightpercent, preferably from about 0.05 to 0.8 weight percent, and morepreferably from about 0.1 to 0.5 weight percent of the composition.

[0030] Any pharmaceutically acceptable 5-α reductase inhibitor may beused in the anti-hair thinning compositions, such as finasteride, SawPalmetto Extract (Serenoa repens), MK-386, LY191704, turosteride, PNU157706, FK-143, GG-745, ONO-9302, and the like, and mixtures thereof. Apreferred 5-α reductase inhibitor is Saw Palmetto Extract (SerenoaSerrulata). The 5-α reductase inhibitor is typically present in anamount sufficient to inhibit conversion of testosterone in the scalp todihydro-testosterone, the latter of which is believed to increase hairthinning. The 5-α reductase inhibitor is typically present in an amountfrom about 0.01 to 1 weight percent, preferably about 0.05 to 0.5 weightpercent, and more preferably about 0.08 to 0.2 weight percent of thecomposition. The hydroxy acid, niacin component, and 5-α reductaseinhibitor together facilitate exfoliation of dead skin, improve bloodcirculation, and ultimately inhibit and/or reduce hair loss.

[0031] In a preferred embodiment, the compositions all contain one ormore surfactants, stabilizers, preservatives, moisturizers, coloringagents, anti-inflammatory agents, anti-oxidants, water, and the like,and mixtures thereof. The water used is preferably deionized water. Itshould be understood that water includes the remainder of a givencomposition after other ingredients are determined. Although anypharmaceutically acceptable surfactant, stabilizer, preservative,moisturizer, or coloring agent may be used, certain compounds ormixtures are preferred as discussed below.

[0032] Preferred surfactants, including both the foaming and non-foamingtype, include sodium laureth sulfate, disodium cocoamphodiacetate, andthe like, and mixtures thereof. The surfactant component may be presentin an amount from about 10 to 90 weight percent, preferably about 20 to80, and more preferably about 30 to 70 weight percent of thecomposition.

[0033] A preferred stabilizer includes glycol stearate. The stabilizer,when used, is typically present in an amount from about 0.1 to 5 weightpercent of the composition.

[0034] Preferred preservatives include tetrasodium ethylene-diaminetetraacetic acid (EDTA), methylparaben, benzophenone-4,methylchloroisothiazolinone, methylisothiazolinone, and the like, andmixtures thereof. Preservatives, when used, are typically present in anamount from about 0.01 to 6 weight percent, preferably about 0.05 to 4weight percent, and more preferably from about 0.1 to 2 weight percent.

[0035] Preferred moisturizers include wheat protein (e.g., laurdimoniumhydroxypropyl hydrolyzed wheat protein), hair keratin amino acids,sodium peroxylinecarbolic acid, panthenol, tocopherol (Vitamin E),dimethicone, and the like, and mixtures thereof. Sodium chloride mayalso be present, particularly when hair keratin amino acids are includedas a moisturizer. Moisturizers are typically present in an amount fromabout 0.01 to 2 weight percent, preferably about 0.05 to 1.5 weightpercent, more preferably from about 0.1 to 1 weight percent of thecomposition.

[0036] Preferred coloring agents include FD&C Green No. 3, Ext. D&CViolet No. 2, FD&C Yellow No. 5, FD&C Red No. 40, and the like, andmixtures thereof. The coloring agents are preferably used, and when usedare typically present in an amount from about 0.001 to 0.1 weightpercent, and preferably from about 0.005 to 0.05 weight percent of thecomposition.

[0037] Preferred anti-inflammatory agents include any pharmaceuticallyacceptable compounds suitable for administration orally or topically,preferably allantoin. The anti-inflammatory agents, when present, areused in an amount sufficient to inhibit or reduce inflammation,preferably in an amount from about 0.1 to 2 weight percent, preferablyfrom about 0.3 to 1.5 weight percent, and more preferably from about 0.3to 1 weight percent of the composition.

[0038] Anti-oxidants of both the enzymatic and non-enzymatic type may beincluded in the compositions and methods of the invention. For example,superoxide dismutase (SOD), catalase, and glutathione peroxidase arenatural enzymatic anti-oxidants used by the body that may besupplemented with the compositions herein. Suitable non-enzymaticanti-oxidants include such as Vitamin E (e.g., tocopherol), Vitamin C(ascorbic acid), carotenoids, Echinacoside and caffeoyl derivatives,oligomeric proanthocyanidins or proanthanols (e.g., grape seed extract),silymarin (e.g., milk thistle extract, Silybum marianum), ginkgo biloba,green tea polyphenols, and the like, and mixtures thereof. Carotenoidsare powerful anti-oxidants, and they include beta-carotene,canthaxanthin, zeaxanthin, lycopen, lutein, crocetin, capsanthin, andthe like. Indeed, any pharmaceutically acceptable compounds suitable foradministration orally or topically may be used as an anti-oxidant in thecompositions. Preferably, the anti-oxidant component includes Vitamin E,Vitamin C, or a carotenoid. The anti-oxidant component, when used, ispresent in an amount sufficient to inhibit or reduce the effects offree-radicals at the scalp. The anti-oxidant component may be present inan amount from about 0.001 to 1 weight percent, preferably from about0.01 to 0.5 weight percent of the composition.

[0039] Application of chemicals to the hair, such as for coloring orother hair treatment, requires the cuticles to be opened, which may beaccomplished by using any of a variety of alkaline components suitablefor application to the hair. It should be understood that theapplication of the acidic component, however, will close or essentiallyclose the cuticle incidental to the methods of managing scalpconditions, as discussed herein. Thus, chemical processing of the hairis rendered more difficult after application of the compositions of thepresent invention. However, when it is desired to specifically protectchemically processed hair, the compositions herein may be administeredsubsequent to, preferably immediately subsequent to, chemical processingof the hair. By “immediately” it is meant that the compositions hereinare administered within 4 hours, preferably within 1 hour, and morepreferably within 30 minutes of the chemical processing. Thus, in apreferred embodiment for protecting chemically processed hair, a patientmay optionally have their hair conventionally shampooed and rinsed,chemically processed, and then have the compositions of the inventionadministered to protect the processing by closing or essentially closingthe cuticle.

[0040] The term “scalp conditions” as used herein means conditionsincluding dandruff, eczema, hair thinning, irritation, psoriasis,scaling, folliculitis, seborrhea or seborrheic dermatitis, and the like.

[0041] The terms “managing” or “management” as used herein includes oneor more of the prevention, treatment, or modification of a condition.

[0042] The term “environmental damage” as used herein means weather orother damage to the scalp or hair from exposure to one or more of water,sun, pollution, overdrying, overteasing, and the like.

[0043] The term “therapeutically effective amount” means that amount ofthe pharmaceutical composition that provides a therapeutic benefit inthe treatment, prevention, or management of scalp conditions.

[0044] The magnitude of a prophylactic or therapeutic dose of thecomposition in the acute or chronic management of scalp conditions willvary with the severity of the condition to be treated and the route ofadministration. The dose, and perhaps the dose frequency, will also varyaccording to the age, body weight, and response of the individualpatient. In general, a preferred topical daily dose range, in single ordivided doses, for the conditions described herein should be from about1 mg to 20,000 mg, more preferably about 2,000 mg to 16,000 mg, and mostpreferably about 6,000 mg to 10,000 mg of the active components (i.e.,excluding excipients and carriers).

[0045] Those of ordinary skill in the art will also understand thattopical effectiveness of pharmaceuticals requires percutaneousabsorption and bioavailability to the target site. Thus, thecompositions and methods of the invention require penetration throughthe stratum comeum into the epidermal layers, as well as sufficientdistribution to the sites targeted for pharmacologic action.

[0046] It is further recommended that children, patients aged over 65years, and those with impaired renal or hepatic function initiallyreceive low doses, and that they then be titrated based on individualresponse(s) or blood level(s). It may be necessary to use dosagesoutside these ranges in some cases, as will be apparent to those ofordinary skill in the art. Further, it is noted that the clinician ortreating physician will know how and when to interrupt, adjust, orterminate therapy in conjunction with individual patient response.

[0047] The term “unit dose” is meant to describe a single dose, althougha unit dose may be divided, if desired. About 1 to 2 unit doses of thepresent invention are typically administered per day, preferably about 1dose per day.

[0048] Any suitable route of administration may be employed forproviding the patient with an effective dosage of the compositionaccording to the methods of the present invention, including oral,intraoral, rectal, parenteral, topical, epicutaneous, transdermal,subcutaneous, intramuscular, intranasal, sublingual, buccal, intradural,intraocular, intrarespiratory, or nasal inhalation and like forms ofadministration. Topical administration is generally preferred for thecompositions and methods of the invention, although oral administrationis preferred for the 5-α reductase inhibitor. Suitable dosage formsinclude dispersions, suspensions, solutions, aerosols, sponges, cottonapplicators, and the like, with topical dosage forms such as shampoosbeing preferred. A sunscreen dosage form is one preferred embodiment formethods and compositions for the management of thinning hair, sinceextra protection is required when more scalp is exposed to harmfulultraviolet radiation. In a sunscreen dosage form, it is preferred toinclude benzophenone-4, which provides the scalp with some sunscreenprotection factor from ultraviolet radiation.

[0049] The pharmaceutical compositions used in the methods of thepresent invention include the active ingredients described above, andmay also contain pharmaceutically acceptable carriers, excipients andthe like, and optionally, other therapeutic ingredients.

[0050] The term “pharmaceutically acceptable salt” refers to a saltprepared from pharmaceutically acceptable non-toxic acids or basesincluding inorganic or organic acids. Examples of such inorganic acidsare hydrochloric, hydrobromic, hydroiodic, sulfuric, and phosphoric.Appropriate organic acids may be selected, for example, from aliphatic,aromatic, carboxylic and sulfonic classes of organic acids, examples ofwhich are formic, acetic, propionic, succinic, glycolic, glucoronic,maleic, furoic, glutamic, benzoic, anthranilic, salicylic, phenylacetic,mandelic, embonic (pamoic), methanesulfonic, ethanesulfonic,pantothenic, benzenesulfonic, stearic, sulfanilic, algenic, andgalacturonic. Examples of such inorganic bases, for potential saltformation with the sulfate or phosphate compounds of the invention,include metallic salts made from aluminum, calcium, lithium, magnesium,potassium, sodium, and zinc. Appropriate organic bases may be selected,for example, from N,N-dibenzylethylenediamine, chloroprocaine, choline,diethanolamine, ethylenediamine, meglumaine (N-methylglucamine), andprocaine.

[0051] The compositions for use in the methods of the present inventionmay include components such as suspensions, solutions and elixirs;aerosols; or other suitable carriers such as starches, sugars,microcrystalline cellulose, diluents, granulating agents, lubricants,binders, disintegrating agents, and the like, with the topicalpreparations being preferred.

[0052] Because of its ease of administration, shampoo represents themost advantageous topical dosage unit form, in which case liquidpharmaceutical carriers may be employed in the composition. Theseshampoos may be prepared as rinse-off or leave-on after-shampooproducts, as well as two stage treatment shampoos. Additionally, thecomposition may also be prepared as a stand-alone conditioner or pre- orpost-shampoo conditioner. In a preferred embodiment, the compositionsare administered as a shampoo, then as a conditioner after the shampoois rinsed away, and optionally in a higher concentration form, such as agel, subsequently thereto. Each of these forms is well understood bythose of ordinary skill in the art, such that dosages may easily beprepared to incorporate the pharmaceutical composition of the invention.

[0053] Pharmaceutical compositions for use in the methods of the presentinvention suitable for topical administration may be presented asdiscrete units including aerosol sprays, each containing a predeterminedamount of the active ingredient, as a powder, stick, or granules, ascreams (e.g., a conditioner), pastes, gels, lotions (e.g., a sunscreen),syrups, or ointments, on sponges or cotton applicators, or as a solutionor a suspension in an aqueous liquid, a non-aqueous liquid, anoil-in-water emulsion, or a water-in-oil liquid emulsion. Suchcompositions may be prepared by any of the methods of pharmacy, but allmethods include the step of bringing into association the carrier(s)with the active ingredient, which constitutes one or more necessaryingredients. In general, the compositions are prepared by uniformly andintimately admixing the active ingredient with liquid carriers or finelydivided solid carriers or both, and then, if necessary, shaping theproduct into the desired presentation.

[0054] Other suitable dosage forms include tablets, troches, capsules,patches, gel caps, magmas, lozenges, plasters, discs, suppositories,nasal or oral sprays, and the like. Tablets, capsules, and gel caps arethe preferred oral dosage unit form for the 5-α reductase inhibitor, inwhich case solid pharmaceutical carriers may be employed. If desired,tablets may be coated by standard aqueous or nonaqueous techniques.

[0055] In addition to the common dosage forms set out above, thecompound for use in the methods of the present invention may also beadministered by controlled release means and/or delivery devices such asthose described in U.S. Pat. Nos. 3,845,770; 3,916,899; 3,536,809;3,598,123; and 4,008,719, the disclosures of which are expresslyincorporated herein by reference thereto.

[0056] For example, a tablet may be prepared by compression or molding,optionally, with one or more accessory ingredients. Compressed tabletsmay be prepared by compressing in a suitable machine the activeingredient in a free-flowing form such as powder or granules, optionallymixed with a binder, lubricant, inert diluent, surface active ordispersing agent. Molded tablets may be made by molding, in a suitablemachine, a mixture of the powdered compound moistened with an inertliquid diluent.

[0057] Desirably, each unit dose, e.g., shampoo, contains from about 1mg to 2,000 mg of the active ingredient, preferably about 200 mg to1,600 mg, and more preferably about 600 mg to 1,000 mg of thecomposition.

EXAMPLES

[0058] The invention is further defined by reference to the followingexamples describing in detail the preparation of the compound and thecompositions used in the methods of the present invention, as well astheir utility. The examples are representative, and they should not beconstrued to limit the scope of the invention.

Example 1 Shampoo for Dandruff Treatment

[0059] A pharmaceutical composition according to the invention may beprepared in the form of a shampoo formulated for dandruff management asset forth below: % by Ingredient Trade Name/Supplier Weight Part ADeionized Water N/A  47 Guar Hydroxypropyl- JAGUAR C-13S  0.1 trimoniumChloride Glycolic Acid GLYPURE-70%  1.5 Glycolic Acid MethylparabenMethylparaben  0.2 Sodium Laureth Sulfate CARSONOL SLES-2  28 GlycolDistearate LEXEMUL EGDS  1 Cocamidopropyl Betaine LONZAINE C  5 Part BLauramide Diethanolamine MONAMID 716  2 (DEA) Part C Salicylic AcidSalicylic Acid,  1.2 powdered, USP Sodium Laureth Sulfate CARSONOLSLES-2  10 Part D Allantoin ALLANTOIN  0.1 Panthenol DL-PANTHENOL 50% 0.3 Dimethicone (and) DOW CORNING 1664  0.05 Laureth-4 and Laureth-23Part E Clotrimazole Clotrimazole, USP  0.5 Alcohol (denatured) SDALCOHOL 40,  1.5 Anhydrous Part F Glycolic Acid GLYPURE-70%  0.15Glycolic Acid Phenoxyethanol Phenoxyethanol  0.7 Methylchloroiso- KATHONCG  0.05 thiazolinone and Methylisothiazolinone Retinyl PalmitateVitamin A Palmitate,  0.02 type P1.7 Tocopherol Vitamin E USP, #60525 0.02 Benzophenone-4 UVINUL MS-40  0.1 FD&C Green No. 3 FD&C Green No. 3 0.02 (CI 42053) (1.0% Solution) Ext. D&C Violet No. 2 Ext. D&C VioletNo. 2  0.2 (CI 60730) (0.10% Solution) Fragrance (Parfum) NaturalFragrance -  0.3 Haarmann & Reimer #A40758/778926 100%

[0060] Deionized water may be metered into the processing tank and highspeed mixing subsequently begun. Guar hydroxypropyltrimonium andglycolic acid are added one at a time. Once the guar component iscompletely dispersed, the mixture is heated to 75° C. The remaining PartA ingredients are then added and mixed until all the solids aredissolved. The mixture is cooled to 60° C. and the Part B ingredientsare added and mixed until uniform. The mixture is then cooled to 50° C.In a separate vessel, Part C is premixed until homogeneous, then addedto the mixture of Parts A & B. Parts A, B, and C are mixed untiluniform. The Part D ingredients are added and mixed until uniform, thencooled to 40° C. Premixed Part E is added and mixed until uniform, thePart F ingredients are added and mixed, and the composition is thencooled to 35° C. The appearance should be an aqua blue, opaque,pearlized, semi-viscous liquid having a pH at 25° C. of between 4 to 5and a viscosity between 5,000 to 9,000 cps (RVT: #4 @ 10 rpm @ 25° C.).

Example 2 Shampoo for Thinning Hair

[0061] A pharmaceutical composition according to the invention may beprepared in the form of a shampoo formulated for management of thinninghair as set forth below: % by Ingredient Trade Name/Supplier Weight PartA Deionized water N/A  51.9 Polyquaternium-10 UCARE Polymer JR-125  0.15Glycolic Acid GLYPURE-70%  1 Glycolic Acid Methylparaben N/A  0.2 SodiumLaureth Sulfate CARSONOL SLES-2  35 Glycol Stearate LEXEMUL EGMS  0.75Phytantriol N/A  0.1 Sodium Lauroyl HAMPOSYL L-30  1.5 SarcosinateCocamidopropyl Betaine LONZAINE C  5 Panthenyl Ethyl Ether EthylPanthenol  0.2 Tetrasodium Ethylene- HAMP-ENE 220  0.03Diamine-Tetraacetic Acid (EDTA) Benzophenone-4 Uvinul MS-40  0.1 Part BLauramide Diethanolamine MONAMID 716  2.2 Part C Lactamide PARAPELLAM-100  0.6 Monoethanolamine (MEA) Sodium Peroxylinecarbolic AJIDEWN-50  0.4 Acid (PCA) Hair Keratin Amino Acids CROTEIN HKP  0.1 andSodium Chloride Part D Saw Palmetto (Serenoa Saw Palmetto Berry  0.1Serrulata) Extract Glycolic Extract Methylchloroiso- KATHON CG  0.05thiazolinone and Methylisothiazolinone FD&C Green No. 3 FD&C Green No. 3 0.005 (CI 42053) (1.0% Solution) FD&C Yellow No. 5 FD&C Yellow No. 5 0.007 (CI 19140) (1.0% Solution) Part E Menthol Menthol Crystals, USP 0.3 Cinnamon (Cinnamomum Essential Oil Blend  0.5 Cassia) Oil,Grapefruit #EE-50098 (Citrus Grandis) Oil, Orange (Citrus AurantiumDulcis) Oil, Petitgrain (Citrus Aurantium Amara) Oil, Peppermint (MenthaPiperita) Oil, Eucalyptus Globulus Oil, Clove (Eugenia Caryophyllus)Oil, and Rosemary (Rosmarinus Officinalis) Oil Fragrance (Parfum)Fragrance - Haarmann &  0.3 Reimer #A40758/778926 100%

[0062] Deionized water may be metered into the processing tank and highspeed mixing subsequently begun. Polyquatemium-10 and glycolic acid areadded one at a time. Once the polymer is completely dispersed, themixture is heated to 75° C. The remaining Part A ingredients are thenadded and mixed until all the solids are dissolved. The mixture iscooled to 60° C. and the Part B ingredients are added and mixed untiluniform. The mixture is then cooled to 50° C. In a separate vessel, PartC is premixed until homogeneous, then added to the mixture of Parts A &B. Parts A, B, and C are mixed until uniform. The Part D ingredients areadded and mixed until uniform, then cooled to 40° C. Premixed Part E isadded and mixed until uniform, the Part F ingredients are added andmixed, and the composition is then cooled to 35° C. The appearanceshould be a light green, opaque, pearlized, semi-viscous liquid having apH at 25° C. of between 5.4 to 6.1 and a viscosity between 6,000 to12,000 cps (RVT: #5 @ 10 rpm @ 25° C.).

Example 3 Shampoo Formulation for Chemically Treated Hair

[0063] A pharmaceutical composition according to the invention may beformulated as a shampoo for protecting chemically treated hair as setforth below: % by Ingredient Trade Name/Supplier Weight Part A Deionizedwater N/A  86.4% Polyquaternium-10 UCARE Polymer JR-125  0.2 GlycolicAcid GLYPURE-70%  0.1 Glycolic Acid Tetrasodium Ethylene- HAMP-ENE 220 0.01 Diamine-Tetraacetic Acid (EDTA) Sodium Laureth Sulfate STEOLCS-230 PCK  10 Glycol Stearate LEXEMUL EGMS  0.1 Methylparaben N/A  0.05Sodium Lauroyl HAMPOSYL L-30  0.1 Sarcosinate Panthenol LiquidDL-Panthenol  0.5 50% Benzophenone-4 UVINUL MS-40  0.05 Part B DisodiumMIRANOL C2M  1 Cocoamphodiacetate CONC. NP Part C Lactamide PARAPELLAM-100  0.5 Monoethanolamine (MBA) Sodium Peroxylinecarbolic AJIDEWN-50  0.5 Acid (PCA) Hair Keratin Amino Acids CROTEIN HKP  0.05 andSodium Chloride Laudimonium HYDROTRITICUM QL  0.01 HydroxypropylHydrolyzed Wheat Protein Part D Methylchloroiso- KATHON CG  0.05thiazolinone and Methylisothiazolinone FD&C Red No. 40 FD&C Red No. 40 0.02 (CI 16035) (1.0% Solution) Part E Jasmine (Jasminum Essential OilBlend  0.3 Officinale) Oil, “Passion” Palmarosa (Cymbopogon Martini)Oil, Sandalwood (Santalum Album) Oil, Patchouli (Pogostemon Cablin) Oil,Nutmeg (Myristica Fragrans) Oil, Grapefruit (Citrus Grandis) Oil, Orris(Iris Florentina) Root Oil, Carnation (Dianthus Caryophyllus) OilPhytantriol N/A  0.02 Part F Glycolic acid GLYPURE-70%  0.1 glycolicacid Part G Deionized water N/A  0.1 Sodium chloride N/A  0.1 100%

[0064] Deionized water may be metered into the processing tank and highspeed mixing subsequently begun. Polyquaternium-10 and glycolic acid areadded one at a time. Once the polymer is completely dispersed, themixture is heated to 75° C. The remaining Part A ingredients are thenadded and mixed until all the solids are dissolved. The mixture iscooled to 60° C. and the Part B ingredients are added and mixed untiluniform. The mixture is then cooled to 50° C. Part C is then added tothe mixture of Parts A & B and mixed until uniform. The Part Dingredients are added and mixed until uniform, then cooled to 40° C.Premixed Part E is added and mixed until uniform, the Part F ingredientsare added in increments as need to obtain the desired pH of 5.7 to 6.5and mixed until uniform. Then Part G is added in increments to obtainthe desired viscosity of 8,000 to 12,000 cps (RVT#5 @ 10 rpm @ 25° C.),and the composition is then mixed and cooled to 35° C. The appearanceshould be a peach-colored, opaque, pearlized, semi-viscous liquid havinga pH at 25° C. of between 5.7 to 6.5 and a viscosity between 8,000 to12,000 cps (RVT: #5 @ 10 rpm @ 25° C.).

Example 4 Professional Scalp Formulation for Dandruff

[0065] A pharmaceutical composition according to the invention may beformulated in a more potent concentration as a shampoo for professionalmanagement of dandruff as set forth below: % By Ingredient TradeName/Supplier Weight Part A Deionized water N/A  74.6%Hydroxyethylcellulose CELLOSIZE QP52,000H  0.3 Part B Disodium Ethylene-HAMP-ENE Na₂  0.03 Diamine-Tetraacetic Acid (EDTA) Glycerin Glycerine99.5%  1 Glycolic Acid GLYPURE-70%  10 Glycolic Acid Part C Deionizedwater N/A  1 Sodium Hydroxide Sodium Hydroxide,  1 pellets (USP/NF) PartD Alcohol (denatured) SD Alochol 40-B,  10 Anhydrous Salicylic AcidSalicylic Acid,  1.8 powder (USP/NF) Part E PPG-5-Ceteth-20 PROCETYL AWS 0.2 Lemongrass (Cymbopogon Lemongrass Oil #65161  0.02 Schoenanthus)Oil Peppermint (Mentha Peppermint Oil #097973-  0.04 Piperita) Oil 0594NGeranium Maculatum Oil Geranium Oil #01491  0.02 100%

[0066] Deionized water may be metered into the processing tank and highspeed mixing subsequently begun. CELLOSIZE QP52,000H is added and heatedat 70° C. until the solids are dissolved. The mixture is cooled to 40°C. The Part B ingredients are added and mixed until uniform. PremixedPart C is then added in increments to obtain the desired pH below, andmixed until uniform. The mixture is cooled to 25° C. and premixed part Dis slowly added and mixed until uniform. Premixed Part E is added andmixed until uniform. The composition should be colorless, clear,semi-viscous liquid having a pH at 25° C. between 3.4 to 3.8 and aviscosity between 1,500 to 2,5000 cps (RVT#5 @ 10 rpm @ 25° C.).

Example 5 Scalp Formulation for Thinning Hair

[0067] A pharmaceutical composition according to the invention may beformulated as a shampoo for management of thinning hair as set forthbelow: % By Ingredient Trade Name Weight Part A Deionized water N/A 82.3% Part B Propylene Glycol N/A  5 Methylparaben N/A  0.2 Part CMenthol Menthol Crystals,  0.03 USP Ethyl Nicotinate  0.05 Cinnamon(Cinnamomum Essential Oil Blend  0.04 Cassia) Oil, Grapefruit #EE-50098(Citrus Grandis) Oil, Orange (Citrus Aurantium Dulcis) Oil, Petitgrain(Citrus Aurantium Amara) Oil Polysorbate 80 TWEEN 80  3 PhytantriolPhytantriol  0.2 Biotin N/A  0.1 Salicylic Acid Salicylic Acid,  0.5powder, USP/NF Capsicum Frutescens Actiphyte of  0.05 Extract andSafflower Capsicum, Lipo S (Carthamus Tinctorius) Oil Part D AllantoinAllantoin  0.5 Tetrasodium EDTA HAMP-ENE 220  0.2 Lactamide Mono-PARAPEL LAM-100  1.5 ethanolamine Panthenyl Ethyl Ether Ethyl Panthenol 1.5 Diazolidinyl Urea GERMALL II  0.3 Cocamidopropyl PHOSPHOLIPID  1.08PG-Dimonium Chloride PTC Phosphate Saw Palmetto (Sereno Saw PalmettoExtract  0.5 Serrulata) Extract Cyanocobalamin Vitamin B₁₂  0.02 YeastExtract (Faex) NAYAD S  1 Yeast Extract (Faex) RESPIROGEN  2 100%

Example 6 Conditioner Formulation for Thinning Hair

[0068] A pharmaceutical composition according to the invention may beformulated as a conditioner for management of thinning hair as set forthbelow: % By Ingredient Trade Name Weight Part A Deionized water N/A 79.5% Hydroxyethylcellulose CELLOSIZE POLYMER  1 PCG-10 MethylparabenN/A  0.2 Benzophenone-4 UVINUL MS-40  0.1 Glyceryl Stearate RITA GMS-55G 2 Stearalkonium Chloride MAQUAT SC-18 85%  2 Cetyl Alcohol LANETTE 16 2.5 Stearyl Alcohol LANETTE 18  2.5 Glycerin Glycerine 99.5%  1 Part BLaurdimonium Hydroxy- HYDROTRITICUM QL  1 propyl Hydrolyzed WheatProtein Panthenol DL-PANTHENOL 50%  1 Hydrolyzed Soy Protein HYDROSOY2000 SF  1 Hydrolyzed Wheat Protein CRODASONE W  1 HydroxypropylPolysiloxane Hair Keratin Amino Acids CROTEIN HKP Powder  1 and SodiumChloride Part C Methylchloro- KATHON CG  0.05 isothiazolinone andMethylisothiazolinone Benzalkonium Chloride BTC-50  0.5 Biotin Biotin 0.05 Ethyl Nicotinate Ethyl Nicotinate  0.05 Witch Hazel Witch HazelDistillate  2 (Hamamelis Virginiana) E02 Distillate FD&C Blue No. 1 FD&CBlue No. 1  0.006 (CI 42090) (1.0% Solution) FD&C Yellow No. 5 FD&CYellow No. 5  0.006 (CI 19140) (1.0% Solution) Part D Cinnamon(Cinnamomum Essential Oil Blend  0.1 Cassia) Oil, Grapefruit #EE-50098(Citrus Grandis) Oil, Orange (Citrus Aurantium Dulcis) Oil, Petitgrain(Citrus Aurantium Amara) Oil, Peppermint (Mentha Piperita) Oil,Eucalyptus Globulus Oil, Clove (Eugenia Caryophyllus) Oil, Rosemary(Rosmarinus Officinalis) Oil Menthol Menthol Crystals, USP  0.5Fragrance (Parfum) Fragrance -  0.5 HAARMANN & REIMER #A40758/ 778926Part E Glycolic Acid GLYPURE-70%  0.5 Glycolic Acid 100%

Example 7 Professional Scalp Treatment for Chemically Treated Hair

[0069] A pharmaceutical composition according to the invention may beformulated in a higher concentration of acid as a professional treatmentfor protection of chemically treated hair as set forth below: % ByIngredient Trade Name Weight Part A Deionized water N/A  73%Hydroxyethylcellulose CELLOSIZE QP52,000H  1 Part B Disodium EDTAHAMP-ENE Na₂  0.2 Glycerin Glycerine 99.5%  5 Panthenol LiquidDL-Panthenol 50%  1 Quaternium-75 FINQUAT CT  1.5 Cetrimonium ChlorideCARSOQUAT CT-429  1.5 Glycolic Acid GLYPURE-70%  12 Glycolic Acid Part CDeionized water N/A  2 Sodium Hydroxide Sodium Hydroxide,  1.5 pellets,USP/NF Part D PPG-5-Ceteth-20 PROCETYL AWS  1 Phytantriol  0.2 YlangYlang (Cananga Ylang Ylang Oil #65040  0.04 Odorata) Oil Jasmine(Jasminum Jasmine Oil #65072  0.01 Officinale) Oil Chamomile (AnthemisChamomile Oil #112528-  0.02 Nobilis) Oil 0395N 100%

Example 8 Professional Scalp Management of Thinning Hair

[0070] A pharmaceutical composition according to the invention may beformulated in a higher concentration of acid for professional managementof thinning hair as set forth below: % By Ingredient Trade Name WeightPart A Deionized water N/A  77.5% Hydroxyethylcellulose CELLOSIZE  1QP52,000H Part B Disodium EDTA HAMP-ENE Na₂  0.2 Glycerin Glycerine99.5%  5 Panthenyl Ethyl Ether Ethyl Panthenol  1 Glycolic AcidGLYPURE-70%  12 Glycolic Acid Part C Deionized water N/A  1.8 SodiumHydroxide Sodium Hydroxide,  1 pellets, USP/NF Part D PPG-5-Ceteth-20PROCETYL AWS  0.2 Phytantriol Phytantriol  0.2 Ethyl Nicotinate EthylNicotinate  0.05 Menthol Menthol Crystals, USP  0.03 Cinnamon(Cinnamomum Cinnamon Oil #65028  0.02 Cassia) Oil Rosemary (RosmarinusRosemary Oil #65138  0.03 Officinalis) Oil Peppermint (Mentha PeppermintOil  0.02 Piperita) Oil #097973-0594N 100%

Example 9 Conditioner for Chemically Treated Hair

[0071] A pharmaceutical composition according to the invention may beformulated as a conditioner for chemically treated hair as set forthbelow: % By Ingredient Trade Name Weight Part A Deionized water N/A  88%Guar Hydroxypropyl- JAGUAR C-13S  0.5 trimonium Chloride Glycolic AcidGLYPURE-70%  0.15 Glycolic Acid Methylparaben N/A  0.15 StearalkoniumChloride MAQUAT SC-18 85%  2 Cetyl Alcohol LANETTE 16  2 Stearyl AlcoholLANETTE 18  2 Trimethylsilylamodi- SF 1708-D1  0.5 methicone Sodium PCAAJIDEW N-50  0.05 Benzophenone-4 UVINUL MS-40  0.1 Part B HydrolyzedWheat Protein CROPEPTIDE W  0.1 and Hydrolyzed Wheat Starch HydrolyzedWheat Protein CRODASONE W  0.5 Hydroxypropyl Polysiloxane PanthenolLiquid DL-Panthenol  1 50% Hydrolyzed Soy Protein HYDROSOY 2000 SF  1Phytantriol Phytantriol  0.3 Polyquaternium-11 GAFQUAT 755N  1 Part CMethylchloroiso- KATHON CG  0.05 thiazolinone and MethylisothiazolinoneBenzalkonium Chloride BTC-50  0.3 FD&C Red No. 40 FD&C Red No. 40  0.012(C1 16035) (1.0% Solution) Jasmine (Jasminum Essential Oil Blend  0.3Officinale) Oil, Palmarosa “Passion” (Cymbopogon Martini) Oil,Sandalwood (Santalum Album) Oil, Patchouli (Pogostemon Cablin) Oil,Nutmeg (Myristica Fragrans) Oil, Grapefruit (Citrus Grandis) Oil, Orris(Iris Florentina) Root Oil, Carnation (Dianthus Caryophyllus) Oil 100%

[0072] Various modifications of the invention in addition to those shownand described herein will be apparent to those skilled in the art fromthe foregoing description. Such modifications are also intended to fallwithin the scope of the appended claims. The foregoing disclosureincludes all the information deemed essential to enable those skilled inthe art to practice the claimed invention.

What is claimed is:
 1. An anti-dandruff pharmaceutical composition foradministration to a scalp comprising: an acidic component comprising ahydroxy acid or tannic acid, or a pharmaceutically acceptable saltthereof, in an amount sufficient to exfoliate at least a portion of thescalp; a vitamin A component in an amount sufficient to inhibitoverproduction of stratum corneum on the scalp; and an anti-growth agentin an amount sufficient to inhibit fungus, yeast, bacteria, or mixturesthereof, present adjacent the scalp.
 2. The pharmaceutical compositionof claim 1, wherein the composition further comprises a pharmaceuticallyacceptable carrier or excipient.
 3. The pharmaceutical composition ofclaim 1, wherein the acidic component comprises an alpha-hydroxy acid,beta-hydroxy acid, or tannic acid, the vitamin A component comprisesretinyl palmitate, and the anti-growth agent comprises clotrimazole. 4.The pharmaceutical composition of claim 3, wherein the acidic componentcomprises glycolic acid, lactic acid, citric acid, salicylic acid, ortannic acid.
 5. The pharmaceutical composition of claim 1, wherein theacidic component is present in an amount from about 0.1 to 8 weightpercent, the vitamin A component is present in an amount from about 0.01to 1 weight percent, and the anti-growth agent is present in an amountfrom about 0.1 to 1.5 weight percent, of the composition.
 6. Thepharmaceutical composition of claim 1, further comprising at least oneof a surfactant, a stabilizer, a preservative, a moisturizer,anti-inflammatory agent, anti-oxidant, and a coloring agent, whichtogether may be present in an amount from about 10.1 to 99.1 weightpercent of the composition.
 7. A shampoo, cream, or gel comprising thepharmaceutical composition of claim
 1. 8. An anti-hair thinningpharmaceutical composition for administration to a scalp comprising: anacidic component comprising a hydroxy acid or tannic acid, or apharmaceutically acceptable salt thereof, in an amount sufficient toexfoliate at least a portion of the scalp; a niacin component present inan amount sufficient to locally increase blood circulation; and a 5-αreductase inhibitor in an amount sufficient to inhibit conversion oftestosterone to dihydro-testosterone.
 9. The pharmaceutical compositionof claim 8, wherein the composition further comprises a pharmaceuticallyacceptable carrier or excipient.
 10. The pharmaceutical composition ofclaim 8, wherein the acidic component comprises an alpha-hydroxy acid,beta-hydroxy acid, or tannic acid, the niacin component comprisesnicotinate, and the 5-α reductase inhibitor comprises at least one offinasteride or Saw Palmetto Extract.
 11. The pharmaceutical compositionof claim 10, wherein the acidic component comprises glycolic acid,lactic acid, citric acid, salicylic acid, or tannic acid.
 12. Thepharmaceutical composition of claim 8, wherein the acidic component ispresent in an amount from about 0.1 to 8 weight percent, the niacincomponent is present in an amount from about 0.01 to 1 weight percent,and the 5-α reductase inhibitor is present in an amount from about 0.1to 1 weight percent, of the composition.
 13. The pharmaceuticalcomposition of claim 8, further comprising at least one of a surfactant,a stabilizer, a preservative, a moisturizer, anti-inflammatory agent,anti-oxidant, and a coloring agent, which together may be present in anamount from about 10.1 to 99.1 weight percent of the composition. 14.The pharmaceutical composition of claim 8, wherein the acidic componentand the niacin component are adapted for topical administration and the5-α reductase inhibitor is adapted for oral administration.
 15. Ashampoo, cream, or gel comprising the pharmaceutical composition ofclaim
 8. 16. A method of managing a scalp condition which comprisesadministering to a patient a therapeutically effective amount of anacidic component comprising a hydroxy acid or tannic acid, or apharmaceutically acceptable salt thereof, a vitamin A component, and ananti-growth agent to inhibit fungus, yeast, bacteria, or a mixturethereof that may be present adjacent the scalp.
 17. The method of claim16, wherein the scalp condition treated is at least one of dandruff,seborrheic dermatitis, psoriasis, or folliculitis.
 18. The method ofclaim 16, wherein the administering is topical.
 19. The method of claim18, wherein the administering is by at least one of a shampoo, aerosolspray, gel, paste, cream, lotion, sponge, emulsion, or ointment.
 20. Themethod of claim 16, wherein about 1 mg to 10,000 mg of the acidiccomponent, vitamin A component, and anti-growth agent are togetheradministered.
 21. The method of claim 16, wherein the acidic component,vitamin A component, and anti-growth agent are administeredconcurrently.
 22. The method of claim 16, wherein the acidic component,vitamin A component, and anti-growth agent are administered concurrentlywith at least one additional pharmaceutical composition for theprevention or treatment of a scalp condition.
 23. The method of claim16, which further comprises administering at least one of a surfactant,stabilizer, preservative, moisturizer, anti-inflammatory agent,anti-oxidant, or coloring agent.
 24. The method of claim 16, wherein theacidic component comprises an alpha-hydroxy acid, beta-hydroxy acid, ortannic acid, the vitamin A component comprises retinyl palmitate, andthe anti-growth agent comprises at least one of triclosan orclotrimazole.
 25. A method of managing hair thinning which comprisesadministering to a patient a therapeutically effective amount of anacidic component comprising a hydroxy acid or tannic acid, or apharmaceutically acceptable salt thereof, a niacin component present inan amount sufficient to locally increase blood supply, and a 5-αreductase inhibitor.
 26. The method of claim 25, wherein theadministering is topical.
 27. The method of claim 26, wherein the acidiccomponent and niacin component are topically administered and the 5-αreductase inhibitor is orally administered.
 28. The method of claim 26,wherein the administering is by at least one of a shampoo, aerosolspray, gel, paste, cream, lotion, sponge, emulsion, or ointment.
 29. Themethod of claim 25, wherein about 1 mg to 10,000 mg of the acidiccomponent, niacin component, and 5-α reductase inhibitor are togetheradministered.
 30. The method of claim 25, wherein the acidic component,niacin component, and 5-α reductase inhibitor are administeredconcurrently.
 31. The method of claim 25, wherein the acidic component,niacin component, and 5-α reductase inhibitor are administeredconcurrently with at least one additional pharmaceutical composition forthe prevention or treatment of a scalp condition.
 32. The method ofclaim 25, which further comprises administering at least one of asurfactant, stabilizer, preservative, moisturizer, anti-inflammatoryagent, anti-oxidant, or coloring agent.
 33. The method of claim 25,wherein the acidic component comprises an alpha-hydroxy acid,beta-hydroxy acid, or tannic acid, the niacin component comprisesnicotinate, and the 5-α reductase inhibitor comprises at least one offinasteride or Saw Palmetto Extract.
 34. A method of treating chemicallyprocessed hair having a plurality of cuticle which comprisesadministering to a patient an amount of an acidic component comprising ahydroxy acid or tannic acid, or a pharmaceutically acceptable saltthereof, in an amount sufficient to essentially close the cuticle andinhibit modification of the chemically processed hair.
 35. The method ofclaim 34, wherein the administering is topical.
 36. The method of claim34, wherein the administering is by at least one of a shampoo, aerosolspray, gel, paste, cream, lotion, sponge, emulsion, or ointment.
 37. Themethod of claim 34, wherein about 1 mg to 10,000 mg of the acidiccomponent is administered.
 38. The method of claim 34, wherein theacidic component is administered concurrently with at least oneadditional pharmaceutical composition for the prevention or treatment ofa scalp condition.
 39. The method of claim 34, which further comprisesadministering at least one of a surfactant, stabilizer, preservative,moisturizer, anti-inflammatory agent, anti-oxidant, or coloring agent.40. The method of claim 34, wherein the acidic component comprises analpha-hydroxy acid, beta-hydroxy acid, or tannic acid.